Mitigate the risk that Excel Spreadsheets introduce to your company.s IT and operational environment under 21 CFR Part 11

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

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Mitigate the risk that Excel Spreadsheets introduce to your company.s IT and operational environment under 21 CFR Part 11

Mitigate the risk that Excel Spreadsheets introduce to your company.s IT and operational environment under 21 CFR Part 11

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Instructor : Bernice Russell Bond

Product Id : 600039

Overview: End User Computing can be audited and control by manual process; using automated tools; or by the ideal method eliminating the need for end user computing by incorporating the computations to information systems controlled by the information technology de

Are you working in the Pharmaceutical, Biotechnology or Medical Devise Industry?

Do you use Excel in your organization to handle data that has a direct or indirect impact on your Quality System.

If you do, ask yourself the following two questions:

Is the spreadsheet fully validated?
Does the spreadsheet comply with 21 CFR Part 11?

Spreadsheet applications underlie countless business functions, from calculations, tracking workflow processes, to key financial reporting. Spreadsheets can offer an instant, concise corporate snapshot that often drives critical decisions with major implications to the big picture. Excel and other spreadsheet programs reside on over 90% of computer desktops globally.

End-user computing generally involves the use of department-developed spreadsheets and databases, which are frequently used as tools in performing daily work. To the extent these spreadsheets are in place, they are an extension of the IT environment and must comply with FDA regulations.

Areas Covered in the Session:

How End User Computing affects your company.
Risk of using spreadsheets to support critical business processes.
How to identify critical spreadsheet
Structured approached to managing spreadsheets
Implementation of controls that protect spreadsheets.
Compliance

Who Will Benefit: The following individuals will benefit from this webinar:

Business Process owners managing spreadsheets/databases
Information Technology personnel who support systems that govern any cGXP process -
Quality Assurance personnel
Quality system auditors

As President of BRUSSELL Consulting, Inc (BCI), Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has worked for business, legal, audit, and IT management groups within various industries including manufacturing, financial and pharmaceutical. She has acquired practical insights, exposure to leading compliance practices, and seasoned judgment based on her work supporting the Compliance and IT Groups of Global Companies. In addition to her experience, Bernice also has the following academic credentials: B.S. in Accounting from Hampton University and an M.B.A with an emphasis in Technology Management from the University of Phoenix.

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